Medtronic adds to SPYRAL HTN Global Clinical Program with late breaking clinical data for SPYRAL HTN-ON MED and GSR-DEFINE
Time in target range (TTR) plays an important role in the management of many chronic diseases, such as diabetes and hypertension, measuring how well a parameter (e.g., blood pressure) is controlled in patients. Specifically, for hypertension, increasing TTR has been shown to be an independent predictor of reductions in cardiovascular risks, including stroke, heart attack, and death.1 In a recent consensus statement by the
"The data presented today at EuroPCR provide meaningful insights into the benefits of RDN through a patient lens, looking at how much time they spend within a target BP range," said
SPYRAL HTN-ON MED 3-Year Data
Results from the first 80 patients in the SPYRAL HTN-ON MED trial demonstrate improved BP control with significantly higher TTR after radiofrequency RDN when compared to sham through three years, regardless of anti-hypertensive medications. TTR for patients treated with RDN (33.7% TTR) was nearly double of sham patients (18.8% TTR) through three years (p=0.023).
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Medtronic Symplicity Spyral system in hypertensive patients prescribed one to three anti-hypertensive medications. The trial enrolled 80 typical uncontrolled hypertensive patients, randomized to RDN (n=38) or sham control (n=42).
The findings build upon the recent three-year safety and efficiency data presented at ACC.22, which demonstrated safe and sustained blood pressure reductions through three years.
"By focusing on TTR in patients with uncontrolled hypertension, we can better understand how RDN can help control blood pressure and sustain a healthy level," said Dr.
GSR-DEFINE 3-Year Data
In the GSR-DEFINE study, improved blood pressure control after radiofrequency RDN is associated with lower risk of major adverse cardiovascular events (MACE) through three years in real-world patients. RDN patients spent 34.9% time in TTR through three years. There was also a 16% decrease in MACE associated with every 10% increase in TTR at 6 months.
GSR-DEFINE is a prospective, all-comer observational study in 222 sites across 42 countries, including 3,000 patients from the GSR study and enrolling up to an additional 2,000 patients.
"Results from this real-world patient setting closely mirror and build upon data from the SPYRAL HTN-ON MED trial showing improved blood pressure control with RDN. The findings from GSR-DEFINE further underscore the long-term safety and effectiveness of the
About the Medtronic Symplicity Spyral™ Renal Denervation System
The Medtronic RDN procedure uses a minimally invasive procedure that delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral renal denervation system is limited to investigational use in
About Medtronic
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1 Fatani N, Dixon DL, Van Tassell BW, Fanikos J, Buckley LF. Systolic Blood Pressure Time in
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